Dr. Peter Cordeiro, chief of plastic and reconstructive surgery at Memorial Sloan-Kettering Cancer Center in Manhattan, and Diane Balma, director of public policy for the Susan G. Komen Breast Cancer Foundation in Dallas, were interviewed about this week's hearing into whether silicone breast implants should be returned to the market.
What is silicone gel?
Silicone is a clear synthetic compound, which has the consistency of Jell-O and possesses a chemical backbone composed of oxygen and silicon atoms.
Why is the FDA reconsidering silicone implants?
Several studies have suggested that the implants are not dangerous and technical advances have improved the devices, say representatives for manufacturers Mentor Corp. and Inamed Corp.
What choice other than silicone implants do patients have?
Saline implants, which are filled with a salt-water solution. The saline devices are encased in silicone.
Are any studies currently investigating silicone gel implants?
Yes. The FDA is overseeing a clinical trial in which the implants are being used in breast reconstruction after mastectomy and for patients who have had previous breast augmentation.
Why do some women choose silicone?
Silicone implants produce a more natural-looking profile and softer cosmetic result. Cordeiro said saline implants feel like a bag of water; silicone implants like a bag of Jell-O.
What are some of the problems with silicone implants?
Problems can include infection, rupture and, most commonly, the formation of scar tissue around the device, which causes a distortion in the breast's shape. Such scarring, which also can occur with saline implants, can require corrective surgery.
When implants rupture, saline can be absorbed into the body but silicone can produce deposits called granulomas. The long-term effects of these deposits remain unknown.
Do silicone implants cause diseases?
In 2000, the Institute of Medicine found no link to autoimmune or connective tissue diseases such as rheumatoid arthritis, lupus and scleroderma, nor did the institute find an association with cancer.
Do patient advocacy groups support the use of silicone implants?
Yes. A coalition of 18 breast cancer patient advocacy groups has signed a letter that has been presented to FDA panelists. There are also groups that insist the implants are dangerous.
Is silicone used in other medical applications?
Silicone is widely used throughout medicine and is the principal compound in synthetic heart valves, prosthetic hip implants and cardiac pacemakers.
